Prescription PatternBRIEF-ANCT05442307
Academic Detailing About Asthma
A study testing asthma education and Other education in people with Prescription Pattern, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
General practices in the Capital Region of Denmark are offered a short educational visit and are randomized to either asthma (intervention) or another topic (control). The change in prescription pattern from before to after the visit is compared between the intervention and control group. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Prescription Pattern
- What is being tested?
- asthma education and Other education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Oct 2021to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- General practices in the capital region of denmark, who owns a regional registration number [ydernummer]
- Want a visit
- Have time for a visit within the study period
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University Hospital Bispebjerg and Frederiksberg
Copenhagen, Capital Region of Denmark, 2400
jon tt Andersen, MD, +45 38 63 57 26
About this study
Official title: Boosting General Practice pRescription by Individual Educational Fast Academic Detailing Visits About Asthma
General practices in the Capital Region of Denmark are offered a short educational visit and are randomized to either asthma (intervention) or another topic (control).
The change in prescription pattern from before to after the visit is compared between the intervention and control group.
Read the detailed description
General practices in the Capital Region of Denmark are offered a short educational visit. They are randomized by address to be offered a visit about either asthma (intervention) or another topic (control).
The prescription pattern of each general practice (as seen by their regional registration number [ydernummer]) who receive a visit is investigated.
The change in prescription pattern from before to after the visit is compared between the intervention and control group.
- Conditions
- Prescription Pattern
- Being tested
- asthma education, Other education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asthma educationBehavioural
A 15 minutes (preferable) one-on-one educational visit about asthma treatment. The main points being: Every person with asthma should be treated with inhaled corticosteroids (ICS). Most patients with asthma should be treated with Bufomix Easyhaler either as needed and/or regularly. Patients should not use short-acting bega2-agonist (SABA) unless they use a medium-ICS-dosis.
Other educationBehavioural
A 15 minutes (preferable) one-on-one educational visit about another topic (NOT asthma).
| Study group | Role | What they receive |
|---|---|---|
| asthma education | Experimental | The general practices in this arm will receive the education visits about asthma. Receives: Behavioral: asthma education |
| Other education | Placebo comparator | The general practices in this arm will receive an educational visit on another topic (PPI). Receives: Behavioral: Other education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in change of prescription of inhaled corticosteroids and long-acting beta2-agonist (ICS+LABA) before and after educational visit in a six months period
Difference in change of number of adult patients with prescriptions on ICS+LABA between asthma-group and placebo-group.
Measured: 6-0 months before and 6-12 months after educational visit
Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit in a six months period
Difference in change of number of adult patients with prescriptions on ICS and SABA as monotherapy to adults between asthma-group and placebo-group.
Measured: 6-0 months before and 6-12 months after educational visit
Secondary outcomes (18)
Difference in change of prescription of ICS+LABA before and after educational visit in one year
Difference in change of number of adult patients with prescriptions on ICS+LABA between asthma-group and placebo-group
Measured: one year before and one year after educational visit
Difference in change of prescription of ICS+LABA before and after educational visit in one year as interrupted time series analysis
Difference in change of number of adult patients with prescriptions on ICS+LABA between asthma-group and placebo-group as interrupted time series analysis
Measured: one year before and one year after educational visit
Difference in change of prescription of ICS+LABA before and after educational visit in one year for each month
Difference in change of number of adult patients with prescriptions on ICS+LABA between asthma-group and placebo-group analyzed by each month in relation to the visit
Measured: one year before and one year after educational visit
Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit one year
Difference in change of number of adult patients with prescriptions on ICS or on SABA as monotherapy to adults between asthma-group and placebo-group.
Measured: one year before and one year after educational visit
Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit one year as interrupted time series analysis
Difference in change of number of adult patients with prescriptions on ICS or on SABA as monotherapy to adults between asthma-group and placebo-group as interrupted time series analysis
Measured: one year before and one year after educational visit
Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit one year for each month
Difference in change of number of adult patients with prescriptions on ICS and on SABA as monotherapy to adults between asthma-group and placebo-group analyzed by each month in relation to the visit
Measured: one year before and one year after educational visit
Difference in change of prescription of the Easyhaler Device before and after educational visit in a six months period
Difference in change of number of adult patients with prescription on the Easyhaler Device between asthma-group and placebo-group
Measured: 6-0 months before and 6-12 months after educational visit
Difference in change of prescription of the Easyhaler Device before and after educational visit in one year
Difference in change of number of adult patients with prescription on the Easyhaler Device between asthma-group and placebo-group
Measured: one year before and one year after educational visit
Difference in change of prescription of the Easyhaler Device before and after educational visit as interrupted time series analysis
Difference in change of number of adult patients with prescription on the Easyhaler Device between asthma-group and placebo-group as interrupted time series analysis
Measured: one year before and one year after educational visit
Difference in change of prescription of the Easyhaler Device before and after educational visit for each month
Difference in change of number of adult patients with prescription on the Easyhaler Device between asthma-group and placebo-group analyzed by each month in relation to the visit
Measured: one year before and one year after educational visit
Difference in change of prescription of long-acting muscarinic antagonist (LAMA) before and after educational visit in a six months period
Difference in change of number of adult patients with prescription on LAMA between asthma-group and placebo-group
Measured: 6-0 months before and 6-12 months after educational visit
Difference in change of prescription of LAMA before and after educational visit in one year
Difference in change of number of adult patients with prescription on LAMA between asthma-group and placebo-group
Measured: one year before and one year after educational visit
Difference in change of prescription of LAMA before and after educational visit as interrupted time series analysis
Difference in change of number of adult patients with prescription on LAMA between asthma-group and placebo-group
Measured: one year before and one year after educational visit
Difference in change of prescription of LAMA before and after educational visit for each month
Difference in change of number of adult patients with prescription on LAMA between asthma-group and placebo-group analyzed by each month in relation to the visit
Measured: one year before and one year after educational visit
Difference in change of cost of each medication group before and after educational visit in a six months period
Difference in change of cost (pharmacy retail price) of SABA, ICS, ICS+LABA, LAMA and ICS+LAMA+LABA to adults between asthma-group and placebo-group
Measured: 6-0 months before and 6-12 months after educational visit
Difference in change of cost of each medication group before and after educational visit in one year
Difference in change of cost (pharmacy retail price) of SABA, ICS, ICS+LABA, LAMA and ICS+LAMA+LABA to adults between asthma-group and placebo-group
Measured: one year before and one year after educational visit
Difference in change of cost of each medication group before and after educational visit as interrupted time series analysis
Difference in change of cost (pharmacy retail price) of SABA, ICS, ICS+LABA, LAMA and ICS+LAMA+LABA to adults between asthma-group and placebo-group
Measured: one year before and one year after educational visit
Difference in change of cost of each medication group before and after educational visit for each month
Difference in change of cost (pharmacy retail price) of SABA, ICS, ICS+LABA, LAMA and ICS+LAMA+LABA to adults between asthma-group and placebo-group analyzed by each month in relation to the visit
Measured: one year before and one year after educational visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start6 Oct 2021
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prescription PatternStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized placebo controlled study
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jón Þór Trærup Andersen, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Jon tt Andersen, MD, Principal investigator, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442307
- Sponsor's protocol ID
- P-2021-709
- Acronym
- BRIEF-A
- Status last verified
- Jun 2022
- First submitted
- 6 Oct 2021
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting General Practice pRescription by Individual Educational Fast Academic Detailing Visits About Asthma
- ClinicalTrials.gov ID
- NCT05442307
- Acronym / sponsor ID
- BRIEF-A / P-2021-709
- Conditions
- Prescription Pattern
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
General practices in the Capital Region of Denmark are offered a short educational visit and are randomized to either asthma (intervention) or another topic (control).
The change in prescription pattern from before to after the visit is compared between the intervention and control group.
Detailed description
General practices in the Capital Region of Denmark are offered a short educational visit. They are randomized by address to be offered a visit about either asthma (intervention) or another topic (control).
The prescription pattern of each general practice (as seen by their regional registration number [ydernummer]) who receive a visit is investigated.
The change in prescription pattern from before to after the visit is compared between the intervention and control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| asthma education | Experimental | Behavioral: asthma educationThe general practices in this arm will receive the education visits about asthma. |
| Other education | Placebo comparator | Behavioral: Other educationThe general practices in this arm will receive an educational visit on another topic (PPI). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- General practices in the capital region of denmark, who owns a regional registration number [ydernummer]
- Want a visit
- Have time for a visit within the study period
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| asthma educationA 15 minutes (preferable) one-on-one educational visit about asthma treatment. The main points being: Every person with asthma should be treated with inhaled corticosteroids (ICS). Most patients with asthma should be treated with Bufomix Easyhaler either as needed and/or regularly. Patients should not use short-acting bega2-agonist (SABA) unless they use a medium-ICS-dosis. | Behavioural | asthma education |
| Other educationA 15 minutes (preferable) one-on-one educational visit about another topic (NOT asthma). | Behavioural | Other education |
Primary outcome
Difference in change of prescription of inhaled corticosteroids and long-acting beta2-agonist (ICS+LABA) before and after educational visit in a six months period
Time frame: 6-0 months before and 6-12 months after educational visit
Difference in change of number of adult patients with prescriptions on ICS+LABA between asthma-group and placebo-group.
Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit in a six months period
Time frame: 6-0 months before and 6-12 months after educational visit
Difference in change of number of adult patients with prescriptions on ICS and SABA as monotherapy to adults between asthma-group and placebo-group.
18 secondary outcomes
Difference in change of prescription of ICS+LABA before and after educational visit in one year
Time frame: one year before and one year after educational visit
Difference in change of prescription of ICS+LABA before and after educational visit in one year as interrupted time series analysis
Time frame: one year before and one year after educational visit
Difference in change of prescription of ICS+LABA before and after educational visit in one year for each month
Time frame: one year before and one year after educational visit
Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit one year
Time frame: one year before and one year after educational visit
Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit one year as interrupted time series analysis
Time frame: one year before and one year after educational visit
Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit one year for each month
Time frame: one year before and one year after educational visit
Difference in change of prescription of the Easyhaler Device before and after educational visit in a six months period
Time frame: 6-0 months before and 6-12 months after educational visit
Difference in change of prescription of the Easyhaler Device before and after educational visit in one year
Time frame: one year before and one year after educational visit
Difference in change of prescription of the Easyhaler Device before and after educational visit as interrupted time series analysis
Time frame: one year before and one year after educational visit
Difference in change of prescription of the Easyhaler Device before and after educational visit for each month
Time frame: one year before and one year after educational visit
Difference in change of prescription of long-acting muscarinic antagonist (LAMA) before and after educational visit in a six months period
Time frame: 6-0 months before and 6-12 months after educational visit
Difference in change of prescription of LAMA before and after educational visit in one year
Time frame: one year before and one year after educational visit
Difference in change of prescription of LAMA before and after educational visit as interrupted time series analysis
Time frame: one year before and one year after educational visit
Difference in change of prescription of LAMA before and after educational visit for each month
Time frame: one year before and one year after educational visit
Difference in change of cost of each medication group before and after educational visit in a six months period
Time frame: 6-0 months before and 6-12 months after educational visit
Difference in change of cost of each medication group before and after educational visit in one year
Time frame: one year before and one year after educational visit
Difference in change of cost of each medication group before and after educational visit as interrupted time series analysis
Time frame: one year before and one year after educational visit
Difference in change of cost of each medication group before and after educational visit for each month
Time frame: one year before and one year after educational visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon tt Andersen, MD principal investigator
University Hospital Bispebjerg and Frederiksberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing asthma education and Other education in people with Prescription Pattern, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jon T. T. Andersen, MD (+45 38 63 57 26, jon.thor.traerup.andersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change of prescription of inhaled corticosteroids and long-acting beta2-agonist (ICS+LABA) before and after educational visit in a six months period (time frame: 6-0 months before and 6-12 months after educational visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.